Apparatus and process for delivering a silicone prosthesis into a surgical pocket

ABSTRACT

A tapered sleeve is provided that includes a lubricating coating on an inner surface. An implant (e.g., a pre-filled silicon breast implant) is introduced into a large end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized end of the apparatus.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/802,332, filed Mar. 13, 2013, which is a continuation of U.S. patentapplication Ser. No. 13/365,065, filed Feb. 2, 2012, now U.S. Pat. No.8,555,893, which is a continuation of U.S. patent application Ser. No.12/228,072, filed Dec. 7, 2007, now U.S. Pat. No. 8,211,173, all ofwhich are incorporated by reference herein in their entireties.Non-provisional application Ser. No. 12/228,072 is a conversion ofProvisional Application No. 61/005,777, filed Dec. 7, 2007, done by wayof a petition under 37 CFR 1.53(c)(3) granted on Feb. 19, 2009. Thisapplication claims the benefit of the Dec. 7, 2007 filing date.

FIELD OF INVENTION

This invention is directed to a delivery apparatus for facilitating theinsertion of a silicone implant, such as a breast prosthesis, into asurgically developed pocket.

BACKGROUND OF THE INVENTION

This invention relates to the placement of silicone implants within apatient's body. Silicone implants have been in worldwide use for anumber of years. While marketing of the implants was halted within theUnited States for over 15 years, the use of silicone implants hasresumed within the United States. One problem with silicone implants isthat the implants are provided in a filled condition and must beinserted into a surgical pocket. As a result, traditional surgicalapproaches require the use of larger incisions in comparison to salineimplants which can be inserted through small incisions which are laterfilled in situ with saline.

While many patients prefer the more natural qualities of silicone,patients remain apprehensive because of the larger incisions andpossibility for visible scars which result from silicone implants.

An additional concern with the use of silicone implants is that thelongevity and integrity of the implants can be compromised by theconventional insertion process. A typical insertion process involveshand manipulation by the surgeon of the implant in order to insert itinto the surgical pocket. Studies have shown that implant failures areoften associated with an area of minor damage to the outer surface ofthe implant. The damaged areas are believed to correlate to excessivepressure applied by hand manipulation of the implant and/or damageassociated with a “nick” of the implant surface by a “touching” injurysuch as a fingernail or insertion that damages the implant.

An additional consideration with respect to silicone implants involvesthe amount of time required to insert the implants. A traditional handmanipulation of an implant into a surgical pocket can take between 10 to20 minutes per implant for even a highly skilled surgical practitioner.Typically, hand manipulation of an implant requires the use of a largerincision and would be done with a saline implant. The amount of timerequired has a direct bearing on the expense of the procedure, thesurgical expense reflecting the surgeon's time, the support staff withinthe operating room, and the amount of time allocated for the surgicalprocedure. Accordingly, any improvements to reduce the time required forimplantation of the silicone implant will have significant cost savingswith respect to the surgical procedure.

Accordingly, there remains room for improvement and variation within theart.

SUMMARY OF THE INVENTION

It is one aspect of at least one of the present embodiments to providean apparatus and a process for facilitating the delivery of a siliconeimplant into a surgically developed pocket.

It is a further aspect of at least one embodiment of the presentinvention to provide for an apparatus and process for facilitating theplacement of a filled silicone implant into a surgical pocket through asurgical incision that is too small for a manual insertion of animplant.

It is a further aspect of at least one of the present embodiments toprovide for an apparatus and process that allows insertion of a siliconeimplant through a sleeve defining a small diameter outlet into a patientwithout direct hand manipulation of the implant.

It is yet a further and more particular aspect of at least one aspect ofat least one of the present embodiments to provide for a process andapparatus that allows for a “touchless” insertion of a silicone implantinto a surgical pocket.

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A fully enabling disclosure of the present invention, including the bestmode thereof to one of ordinary skill in the art, is set forth moreparticularly in the remainder of the specification, including referenceto the accompanying drawings.

FIG. 1 is a perspective view of a prosthetic insertion sleeve along witha silicone prosthesis.

FIG. 2 is a picture of the insertion sleeve with the silicone implantpositioned within the sleeve and showing further hand manipulation ofthe implant via the sleeve.

FIG. 3 is a view similar to FIG. 2 showing additional manipulation ofthe prosthesis through the sleeve and illustrating a portion of theprosthesis exiting a tapered end of the sleeve.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference will now be made in detail to the embodiments of theinvention, one or more examples of which are set forth below. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations can be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment can be used on another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncover such modifications and variations as come within the scope of theappended claims and their equivalents. Other objects, features, andaspects of the present invention are disclosed in the following detaileddescription. It is to be understood by one of ordinary skill in the artthat the present discussion is a description of exemplary embodimentsonly and is not intended as limiting the broader aspects of the presentinvention, which broader aspects are embodied in the exemplaryconstructions.

In describing the various figures herein, the same reference numbers areused throughout to describe the same material, apparatus, or processpathway. To avoid redundancy, detailed descriptions of much of theapparatus once described in relation to a figure is not repeated in thedescriptions of subsequent figures, although such apparatus or processis labeled with the same reference numbers.

As seen in reference to FIGS. 1-3, a sleeve 10 is provided having ageneral conical shape and which defines a first opening 12 at a largerend of the sleeve and a smaller opening 14 along the tapered terminaltip of sleeve 10. As best seen in reference to FIG. 1, sleeve 10 may beprovided by a material which is sufficiently flexible and which enablesthe sleeve 10 to assume a flattened configuration for storage andshipping.

As seen in reference to FIGS. 2 and 3, when an implant 20, such as asilicone implant, is placed through opening 12 into the interior ofsleeve 10, sleeve 10 can be manipulated to conform to the shape of theimplant 20 as well as to apply pressure to direct the implant 20 alongthe length of the sleeve and toward opening 14.

Preferably, sleeve 10 is of a flexible material. In one embodiment ofthe invention, sleeve 10 can be provided by a fabric material such as aplastic-containing fabric which is pliable yet resistant to stretching.It is also envisioned that use of a transparent plastic or othersuitable polymer material which has sufficient properties includingflexibility and non-elasticity may be used. It is believed that thereare advantages to using a transparent or semitransparent material toassist the surgeon in proper orientation of the implant 20 within theinterior of sleeve 10. Suitable transparent materials may includeMylar®, plastics made from Tygon® brand of plastics, vinyls, polyvinylchloride, and other similar materials. One suitable material which isflexible and transparent includes compositions of ethylene andalpha-olefin copolymers such as the compositions used in IV saline bags.Suitable multilayer films and sealed structures are taught in U.S. Pat.No. 6,743,523 and U.S. Pat. No. 7,267,885 both assigned to BaxterInternational Inc., and which are incorporated herein by reference. Asdisclosed therein, suitable films heat sealed to form suitablecontainers, are transparent with minimal hazing, and can be sterilizedusing gas sterilization or heat with intact seals and remainsufficiently flexible and pliable for the necessary manipulationdescribed herein.

Other attributes of sleeve 10 include the ability to provide sleeve 10as a sterile component. Accordingly, the material must be capable ofwithstanding at least one of several conventional sterilizationtechniques such as a steam autoclave, chemical gas sterilization, orirradiation. Additionally, the interior surface of sleeve 10 maypreferably have a low coefficient of friction to facilitate passage ofthe implant 20 through the sleeve 10. It has been found that using asurgically appropriate lubricant will facilitate passage of the implant20 through the interior of sleeve 10. Such lubricants may be applieddirectly to the implant 20 or the sleeve can be coated with lubricant orsupplied pre-coated with a lubricant that is already present withinsleeve 10.

Since the size of silicone implants 20 may vary in a range from about150 cc to about 800 cc, the dimensions of opening 14 may be varied toaccommodate various size implants 20. Preferably, sleeve 10 is providedwith an opening 14 sized to fit the smallest implant. The tip opening 14may be enlarged by cutting portions of the sleeve to provide a largeropening. If desired, indicia may be present on the exterior of sleeve 10to allow the cutting of the sleeve to the proper dimensions for the sizeof the implant 20.

Alternatively, the tip opening 14 can have a diameter sized to allow thelargest standard implant of 800 cc to exit the sleeve. According to thisinvention, it has been found that an opening 14 having a diameter ofabout 6 cm will allow delivery of the implant into the surgical pocket.As described below, use of an optional tip would allow for a sleeve tobe provided having a single opening size to accommodate the largestimplant. Selection of an appropriate tip can then be made based upon thesize of the implant.

While it is believed preferable that sleeve 10 be provided from a singlestructural substrate, it is also recognized that an equivalent devicecan be provided of a flexible sleeve 10 having a separate inner liner(not illustrated) which may be present within the interior of sleeve 10.The liner could either be integral with sleeve 10 or may be a separatelayer of material manually inserted within the interior of sleeve 10 atthe time of use.

The larger opening 12 of sleeve 10 allows the implant to be placedwithin the sleeve with little force or manual manipulation. When theimplant is within the interior of sleeve 10, the larger opening may betwisted closed as seen in FIGS. 2 and 3. Thereafter, the surgeon is ableto apply manual pressure via the sleeve to the implant 20. The surgeonis thus able to apply pressure to the implant, forcing the implanttoward the smaller opening 14. As seen in reference to FIGS. 2 and 3,the implant can be forced through the small opening 14.

As the surgeon is manipulating the implant through sleeve 10, theopening 14 is placed within the surgical pocket designed for receivingthe implant. Accordingly, tip 14 is inserted through an incisionassociated with the surgical pocket. As the implant is forced throughopening 14, the surgical pocket can be manipulated slightly to create avacuum that assists in the placement of the implant into the pocket.Additionally, another useful feature of the apparatus and process isthat as approximately half of the implant 20 has been exerted throughopening 14, the remainder of the implant will flow through the sleevewithout additional manipulation. Accordingly, once the opening 14 ispositioned within the surgical pocket, implant 20 can be manipulated sothat the prosthesis 20 is forced into the surgical pocket. The surgeonis able to control the positioning and orientation of the implant 20 byproper rotation and positioning of the sleeve 10 containing the implant20.

It has been found that use of a sleeve 10 can greatly reduce the amountof time required for insertion of an implant 20. It has been found thatthe step of inserting a simple implant can occur within a timeframe ofabout 3 to 20 seconds minutes as compared to a time interval of 5 to 15minutes for a traditional hand manipulation of an implant. Additionally,because the implant can be inserted through a small opening, the size ofthe surgical incision can be made smaller than would otherwise berequired for a silicone implant.

The use of the sleeve 10 and implant 20 can be used with incisions. Forinstance, periareolar, trans axillary, intramammary incisions can beused with the above process and apparatus for insertion of an implant.

In accordance with this invention, it has been found beneficial toinitially lubricate the exterior of implant 20 with an appropriatesurgical lubricant such as K-Y® brand sterile lubricant. Followinglubrication, the lubricated implant 20 is placed within the sleeve 10and the implant 20 is forced through opening 14 as a pre-lubricationstep. Following this pre-lubrication step, the implant can again beplaced within the sleeve and subsequently inserted into the patient'ssurgical pocket.

It is also envisioned that, depending upon the coefficient of frictionof the interior of sleeve 10 and/or any associated liner, it may bepossible to provide other types of lubricants, including dry or powderedlubricant products to the interior of sleeve 10. Such lubricants areactivated by being moistened and would provide an alternative tomanually coating the prosthesis with a lubricant.

If desired, sleeve 10 can further define a structural tip (notillustrated) in association with opening 14. The tip could be providedof a more elastic material that facilitates insertion of the tip intothe surgical pocket. For instance, a separate tip could provide for anextension beyond the existing opening 14 and which would have a narrowerinitial diameter providing a longer tip which may be more easilyinserted within the interior of a surgical pocket. The ability of anoptional tip to expand allows the implant 20 to pass through sleeve 10and opening 14 while positioning the exiting implant 20 further withinthe surgical pocket. The use of the tip is believed beneficial in thatit prevents the passage of the implant from extruding the sleeve fromthe incision. In other words, the tip provides a deeper positioning forthe sleeve 10 more accurately directs the placement of the implantwithin the surgical pocket. The use of an expandable tip may facilitatethe insertion time and lessen the learning curve for surgeons who areusing the sleeve 10.

An important attribute of sleeve 10, including any optional tipstructure 14, is that the interior surface of sleeve 10, includingopening 14 and any associated tip member, must provide for a smooth andsubstantially uninterrupted passageway. It is important that any seamsthat may be formed or abutments between one type of material to anotheror from opening 14 to an associated tip must be of a sufficientsmoothness such that the surface of the implant 20 is not degraded.Accordingly, it is envisioned that sonically welded seams or the use ofa unitary extrusion process is desired for forming appropriate sleeves10. In addition, to the extent opening 14 may be “cut to size”, it isimportant that the material, once cut, not present any cutting artifactsor roughened edges that could damage the implant 20. Similarly, theidentical concerns must be met by any optional tip used with sleeve 10such that the material of the tip as well as its method of attaching thetip to the sleeve 10 and sleeve opening 14 must not present anypotential implant contact surfaces that could result in damage to theimplant.

Although preferred embodiments of the invention have been describedusing specific terms, devices, and methods, such description is forillustrative purposes only. The words used are words of descriptionrather than of limitation. It is to be understood that changes andvariations may be made by those of ordinary skill in the art withoutdeparting from the spirit or the scope of the present invention which isset forth in the following claims. In addition, it should be understoodthat aspects of the various embodiments may be interchanged, both inwhole, or in part. Therefore, the spirit and scope of the appendedclaims should not be limited to the description of the preferredversions contained therein.

1. An apparatus for inserting an implant into a surgical pocketcomprising: a conical sleeve defining an interior cavity having a firstterminus and a second terminus and an interconnecting main body, saidfirst terminus having a large diameter than said second terminus, saidsecond terminus being tapered to a reduced diameter outlet, said secondterminus further defining a series of indicia for predetermineddimensions; said first terminus and said main body comprising aflexible, non-elastic sheath selected from a material consisting offabric, plastic, Mylar®, nylon, and combinations thereof; wherein whenan implant is positioned within an interior of said conical sleevethrough said first terminus, said main body is manually manipulated toapply a directional pressure to said implant, forcing the implant alongthe length of the conical sleeve and existing through said secondterminus into the surgical pocket.
 2. The apparatus according to claim 1wherein said interconnecting main body is formed of a transparentmaterial.
 3. The apparatus according to claim 1 wherein said secondterminus is rigid.
 4. The apparatus according to claim 1 wherein saidsecond terminus may be cut along the length said second terminus,thereby providing a larger diameter opening to aforesaid secondterminus.
 5. The apparatus according to claim 1 wherein an interior ofsaid conical sleeve has a low coefficient of friction.
 6. The apparatusaccording to claim 1 wherein said flexible main body may be twisted toprovide a reduced volume to the conical sleeve.
 7. An apparatus forinserting an implant into a surgical pocket comprising: a tapered sleevedefining an interior cavity, said tapered sleeve having a first terminusand a second terminus, said first terminus having a larger diameter thansaid second terminus, said first terminus and said second terminus eachdefining a respective opening; wherein when an implant is positionedwithin an interior of said tapered sleeve through said opening of saidfirst terminus, said sleeve can be manually manipulated to applydirectional pressure to said implant, forcing said implant along alength of said tapered sleeve, said implant exiting through the openingof said second terminus.
 8. The process of inserting a prosthesis into asurgical pocketing comprising: providing a tapered sleeve defining aninterior cavity, said tapered sleeve having a first terminus and asecond terminus, said first terminus having a larger diameter than saidsecond terminus, said first terminus and said second terminus eachdefining a respective opening; placing with an interior of said taperedsleeve a silicone implant; positioning said terminus within a surgicalpocket; manipulating said tapered sleeve and applying pressure to saidimplant, directing said implant toward said second terminus;manipulating said implant through said tapered sleeve, thereby forcingsaid implant through said opening of said second terminus, said implantbeing deposited within said surgical pocket.
 9. The apparatus accordingto claim 7 wherein said second terminus further defines an elastic tip,said elastic tip providing communication from an interior of said sleeveto an exterior of said sleeve through said second terminus.
 10. Theapparatus according to claim 7 wherein said interior cavity of saidtapered sleeve further defines a liner.
 11. The process according toclaim 8 wherein said step of providing a tapered sleeve further definesproviding a tapered sleeve having a lubricant applied to a surface ofsaid interior cavity.
 12. The process according to claim 8 wherein saidstep of placing within an interior of said tapered sleeve a siliconeimplant further comprises applying a lubricant to at least one of eitheran interior of said tapered sleeve or an exterior of said siliconeimplant.